AU2006220045B2 - Film dressing comprising an application aid - Google Patents

Film dressing comprising an application aid Download PDF

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AU2006220045B2
AU2006220045B2 AU2006220045A AU2006220045A AU2006220045B2 AU 2006220045 B2 AU2006220045 B2 AU 2006220045B2 AU 2006220045 A AU2006220045 A AU 2006220045A AU 2006220045 A AU2006220045 A AU 2006220045A AU 2006220045 B2 AU2006220045 B2 AU 2006220045B2
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foil
supporting
polymer film
grip
grip strip
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AU2006220045A1 (en
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Axel Eckstein
Jochem Effing
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Paul Hartmann AG
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Paul Hartmann AG
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/023Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Adhesive Tapes (AREA)
  • Pens And Brushes (AREA)

Abstract

The invention relates to a film dressing (20, 30, 50) comprising a polymer film (1) and an application system for permitting an improved ease of use of said film dressing. According to the invention, the application system is located on the first side of the polymer film (1) and comprises at least one first and one second supporting film (22a, 22b, 32a, 32b, 32c, 52a, 52b). At least one first grip strip (25, 35, 55) is formed on the first supporting film and at least one second grip strip (26, 36, 56) is formed on the second supporting film. At least the first grip strip (25, 35, 55) comprises a grip surface that enables the grip strip (25, 35, 55) to be grasped and the first grip strip (25, 35, 55) at least partially overlaps the second grip strip (26, 36, 56).

Description

-1 Title: Foil dressing comprising an application aid Description The invention relates to a foil dressing with a polymer film and an application system to improve the ease of use of the foil dressing. Application aids for adhesive bandages or wound dressings have been known for quite some time. These application aids are particularly being used in film or foil dressings. Foil dressings are thin, usually transparent, semi-permeable films or foils out of polymer material. The semi-permeability of the foils prevents the invasion of bacteria or moisture while allowing a sufficient exchange of oxygen and condensation between the skin to be covered and the outer surroundings of the foil dressing. These film or foil dressings are used in multiple applications, for example as incision foil for the sterile covering of surgery wounds, as water-proof cover of wound dressings that absorb exudates as well as for the positioning of syringes or catheters. Due to the minimal thickness of these films or foils and their respective instability, these foil dressings are equipped with various application aids. Most of these application aids use an additional supporting layer, which is removed during or after the application of the foil dressing. The patent literature has also known film wound dressings for quite some time. EP 81 990 B1 thus describes an adhesive wound dressing that consists of a thin polymer film. This polymer film is coated on one side with an adhesive material that adheres to the skin, which in turn is covered with a removable layer. On the other side, which during application is opposite of the body, the polymer film also has an easily removable support layer to improve the ease of use, which consists of a fibrous -2 material, for example, a non-transparent non-woven material. This support layer has the same size as the polymer film. EP 690 706 Bl describes an adhesive wound dressing, which has a carrying layer to aid the ease of application of a polymer film, which is comprised by a wound dressing. This carrying layer completely covers the polymer film and can be removed from the polymer film in two steps. For this purpose, a center section is removed from the carrying layer, whereas in the next step a frame section is removed. The fact that it is difficult for the user to grasp the carrying layer of this wound dressing is unfavorable. Additionally, EP 951 263 B1 describes an adhesive foil dressing, where at least one two-part removable protective layer covers the adhesive side and where its non-adhesive second side comprises a one-part support layer. The support layer in this foil dressing is hinge-like attached to the protective layer on two opposite sides so that the support layer is removed simultaneously with the protective layer. EP 473 918 Bl describes a foil dressing that comprises a one-sided supporting foil, which in turn has one grip strip on each of the two opposite sides. This position of the grip strips has the disadvantage that there is no pre determined direction for removing the supporting foil. EP 985 931 Al describes a dressing material on a foil basis, which comprises a non-adhesive gripper in the peripheral area of the foil. The non-adhesive side of the foil comprises a one-part support layer, which is equal to the size of the foil and comprises at least one grip strip. By pulling the gripper in the direction of the adhesion, the applied foil can again be removed -3 painlessly. The European patent specification EP 630 628 B1 established a film dressing that comprises for the ease of application a two-part supporting foil. This supporting foil is larger than the film to be applied and completely covers it. In order to remove the supporting foil, the supporting foil comprises an additional adhesive removal strip, which is positioned above the intersection line of the supporting foil and for handling purposes has two non adhesive peripheral areas that serve as grip strips. This additional removal strip serves to remove only a portion of the supporting foil, whereas the second part of the supporting foil remains on the polymer film. WO 97/25012 Al suggests a foil dressing which is provided either continuously or only on two opposing peripheral areas of the foil with a two-part supporting layer. If the supporting layer is continuously attached to the foil dressing, then gripper supports may be positioned on the supporting foil. The adhesive protective layer opposite of the supporting layer is divided into three sections. These protective rights present various alternative solutions to film and foil dressings with various application systems. The foil dressings which have been suggested as a solution in these protective rights are viewed in part as too complicated in their construction and too complicated in their application. Furthermore, the foil dressings with application aids suggested in these protective rights all exhibit a rigidity which is considered too high in respect of the very flexible polymer film that is actually to be applied. This flexibility of the foil dressings is necessary, however, to apply the polymer films, which are actually to be applied, accurate and wrinkle-free.
-4 It would be advantageous of the present invention to present a foil dressing with application system which has a simple structure and yet assures wrinkle-free application of the polymer film. Another advantage of the present invention would be to offer a foil dressing where its application system comprises at least two supporting foils which can only be removed in one sequence that is unmistakable and consistent. Another advantage would be to offer a foil dressing which can be applied safely and accurately according to its intended application area. At the same time, it would be possible to apply the foil dressing universally without any limitation to shape or size. In a first aspect of the present invention, there is provided a foil dressing comprising a polymer film and an application system for permitting an improved ease of use of said foil dressing, in which the application system is located on the first side of the polymer film and comprises at least one first and one second supporting foil, wherein at least one first grip strip is formed on the first supporting foil and at least one second grip strip is formed on the second supporting foil, in which at least the first grip strip comprises a grip surface that enables the grip strip to be grasped and the first grip strip at least partially overlaps the second grip strip. The "Application system" according to embodiments of the present invention shall include everything that permits the improved ease of use of the polymer film and comprises at least two supporting foils and in addition to these supporting foils comprises at least two grip strips which are formed on said supporting foils. "Forming" in this context shall mean the combining of two similar or two different materials which are separable or inseparable with one another by means of adhesives, pressure, thermal energy, ultrasonic applications or other procedures. The -5 grip strip may therefore presently be an additional material component, whereas the grip strip may be removed from the polymer film with at least one supporting foil. Furthermore, for the ease of understanding in the context of the present invention, a film or polymer film shall always refer to the film or polymer film actually to be applied, for example a wound dressing; in contrast, a foil such as foil dressing, supporting foil, cover foil or release foil and/or polymer foil shall always refer to a part of the application system; that means the difference between film and foil in this case only refers to the function of the components. No distinction shall be made in respect of the material between the terms of film and foil. This positioning of the grip strips provides the user with a particularly simple means to manipulate in each case only the upper-most first grip strip as the first grip strip and therefore remove a first supporting foil as the first foil from the polymer film. The user is only able to remove a second supporting foil in the second step with the aid of a second grip strip. This determines a succession in the removal of the supporting foils and provides a particularly safe means of handling the foil dressing. In a first preferred embodiment of a foil dressing according to the present invention, the first grip strip comprises a grip area that can be determined by the user when grasping said grip strip, preferably designed as a rear grip device of at least 2 cm 2 , particularly at least 5 cm2 and especially preferred of at least 7 cm2. It is particularly intended that the first grip strip completely overlap the second grip strip. It has been proven particularly safe to manipulate when the first grip strip comprises an exposed grip area of at least 2 cm 2 , particularly at least 4 cm 2 and especially preferred of at -6 least 6 cm 2 . This exposed grip area is in this case the section of the grip area that marginally protrudes the second grip strip. In another preferred embodiment of a foil dressing, the second grip strip comprises a grip area that can be determined by the user when grasping said grip strip, preferably designed as rear grip device of at least 2 cm 2 , particularly at least 3 cm 2 and especially preferred of at least 4 cm 2 . Another embodiment of the present invention illustrates that the area of the polymer film, which is covered by the supporting foils, is smaller than the first layer of the polymer film. The polymer film therefore has at least one area without a supporting foil. The foil dressing has particularly in this embodiment two or more supporting foils, where their combined contact area is less than 97 % and particularly less than 94 % of the first layer of the polymer film to be applied. The advantage of such a foil dressing with at least one area without a supporting foil is the fact that this area of the polymer film, which is not covered by a supporting foil, due to the higher flexibility in comparison to the polymer film with supporting foil can function as a joint during the application of the foil dressing. A relatively rigid material can therefore be used as supporting foil, which at the same time assures precise application. In a familiar supporting foil consisting of multiple parts which completely covers the polymer film, the choice of supporting materials must be limited to relatively flexible materials in order to assure precise application of the polymer film. In particular, a first area that is not covered by the supporting foils can be positioned at the edge of the polymer film. An edge shall be understood as every section -7 of an area, which extends from the border of an area into the interior of an area, whereas the area extension of the edge is smaller than 50 % of the entire area. This provides a foil dressing, which favorably comprises an area, which comprises a flexibility that is pre-determined by the polymer film itself and assures an easy first positioning of the film to be applied, where at the same time the supporting foils assure secure handling in the additional areas. It has been proven that it is particularly easy and safe to manipulate when one of the supporting foils has in at least one point of its outer edge a distance from the outer edge of the polymer film of at least 2 mm, particularly at least 3 mm and especially of at least 5 mm. Particularly preferred is a distance, which has in each point of the edge of the supporting foil an equal distance of at least 2 mm, particularly at least 3 mm and especially at least 5 mm to the outmost edge of the polymer film. Another embodiment of the present invention illustrates that a grip strip at least partially overlaps an area of the polymer film that is not covered by the supporting foils. It is also possible that the grip strip completely overlaps the area that is not covered by the supporting foil. The application system can furthermore comprise the same size as the polymer film. The same size in this context refers to a size in respect of the contact surface, that means the circumferential limitations of the application system and the polymer film are aligned. Due to the same size of the application system and the polymer film, and due to the fact that the grip strip is only formed on the supporting foil and is not connected to the polymer film, it is assured that in addition to the previously described high flexibility within the area not covered by the supporting foil the entire film is covered as well and therefore also completely protected during its application.
-8 In a further embodiment of the invention, the foil dressing can comprise a first area between the supporting foils which is not covered by the supporting foils. The distance between both supporting foils is preferably in each point at least 2 mm, particularly 3 mm and especially 5 mm. Particularly preferred is an application system that has two supporting foils, which in each point have the same distance to one another. It has been proven particularly safe to manipulate when the first grip strip completely overlaps the uncovered area of the polymer film as well as the second grip strip. This assures that in each case, the user can only manipulate the upper-most first grip strip as the first grip strip and thereby removes the first supporting foil from the polymer film and the entire polymer film is covered by the application system. If the foil dressing comprises an application system with two supporting foils and a first area without supporting foil is intended between the supporting foils, separate from this first non-covered area a second area can be designed which is also not covered by a supporting foil. This second area can furthermore preferably be covered by a grip strip. Another design is also possible where this second area is covered neither by a supporting foil nor by a grip strip. In a preferred version, this second non covered area of the polymer film is positioned at one edge of the foil dressing. The foil dressing in this manner comprises a joint within the dressing as well as an area for its initial positioning. If an application system is intended that comprises more than two supporting foils, then each supporting foil can be assigned to a grip strip. In a particularly preferred embodiment, two supporting foils may be assigned to one grip strip. In particular, in one foil dressing with three supporting foils, two supporting foils can be assigned to -9 one grip strip. With this arrangement and/or assignment of the grip strips on the supporting foils, two separate supporting foils can be removed in one-step. Transparent or translucent foil materials are particularly intended as supporting foils. However, opaque or non-transparent foil materials can be used alternatively. Used as supporting foil are particularly those foils that are manufactured from polyester, polyethylene, polypropylene, polyvinylchloride, polystyrene, polyamide, polycarbonate, cellulose ester, ethylene vinyl acetate, polyvinyl acetate, polyvinyl alcohol and/or combinations thereof. Particularly preferred are supporting foils from transparent polyester or polyethylene or polypropylene. At the same time, it has been proven to be particularly preferable when the thickness of the supporting foils are adjusted to comprise a thickness of 15 to 80 pm, particularly of 20 to 60 pm and especially of 20 to 40 pm. In order to manufacture a grip strip, the same materials can be used that are used for the supporting foils. In a particularly preferred embodiment, the grip strip is manufactured from a foil material that is more flexible than the supporting foil. If an application system is intended that comprises two or more supporting foils and two or more grip strips, then all grip strips are manufactured from one material that is more flexible than any supporting foil. This assures that the grip strips are very easy to grasp. In another particularly preferred embodiment with two grip strips, it is intended that the grip strip of the first supporting foil is more flexible than the grip strip of the second supporting foil. At the same time, it is also advantageous if the second grip strip completely overlaps the first grip strip. An activation device can be provided in addition to a system with two grip strips that is positioned between the first and the second grip strip. This activation device -10 can for example be an additional adhesive strip with an adhesive strength that is different for the contact surface of each side. When using such foil dressings, one first grip strip, which is positioned above the second grip strip, can for example be grasped and with this grip strip the activation device and one supporting foil can be removed from the polymer film, whereas the second grip strip is hence simultaneously activated and/or lifted up in such manner that it is easier for the user to grasp. In a foil dressing according to an embodiment of the present invention, polymer films can be particularly used that are highly permeable to condensation. For this, those films are particularly practical that are manufactured from polyurethane, polyether urethane, polyester urethane, polyether-polyamide urethane, polyacrylate or polymethacrylate. Particularly preferred as polymer film is a polyurethane film, polyester urethane film or polyether urethane film. Most particularly preferred are also such polymer films that have a thickness of 15 to 50 pm, particularly of 20 to 40 pm and especially of 25 to 30 pm. The condensation permeability of the polymer film in a foil dressing according to the present invention is preferably at least 750 g/ m 2 / 24 hrs., particularly at least 1000 g/ M 2 / 24 hrs., and especially at least 2000 g/
M/
2 24 hrs. (measured according to DIN 13726). An adhesive can be applied on the second side which is opposite of the application system of the polymer film to be applied. This application can be continuously as well as discontinuously or only in certain areas. The applied adhesive can be a common adhesive, particularly an acryl adhesive or a pressure-sensitive adhesive on polyurethane basis. Preferred are gel adhesives, especially on polyurethane basis, particularly water-based polyurethanes. Especially preferred are hydro-gel adhesives, particularly on water-based acrylics.
-11 In a preferred embodiment, the basic weight of the adhesive is 20100 g/m 2 , particularly 35-50 g/m 2 , whereas the adhesive can be applied discontinuously, but preferably continuously. The condensation permeability of the polymer film which has been prepared with adhesive is preferably at least 1000 g/ M 2 / 24 hrs, particularly preferred 1200 g/ M 2 / 24 hrs, and especially preferred at least 2000 g/ M 2 / 24 hrs. (measured according to DIN EN 13726). According to a specific embodiment of the present invention, the foil dressing on the second side of the polymer film opposite of the application system can be continuously coated with an adhesive and the adhesive be protected with a cover paper. Any commonly available silicone paper or foil as well as a paper or foil coated with a fluoride combination can be used as a cover layer. If the foil dressing is to be produced as a wound dressing, according to a further embodiment a wound pad or wound cushion must be positioned on the second side of the polymer film, which during the application is positioned towards the body. Such foil dressing is particularly suited as wound cover when the wound pad or cushion is adhesively attached to the polymer film. This wound cushion can be made of fleece, therefore a non-woven material. This fleece is preferably a hydrophilic fibrous material such as cotton, viscose, cellulose and polyester or their combinations, preferably with hydrophilic polyethylene or polypropylene. Instead of the wound cushion or in addition to the wound cushion, the foil dressing can on the second side of the polymer film, which during the application is positioned towards the body, particularly be provided with a layer that promotes the healing of the wound. A layer that -12 promotes the healing of the wound means any layer that is used for treatment on moist wounds. Particularly preferred here are hydrogels based on polyurethane, acrylics or water-soluble celluloses or combinations thereof, which comprise water content of at least 50 % in relation to the total weight of the hydrogel. These hydrogels can be applied directly to the wound cushion as well as to the second side of the polymer film. In order to provide a foil dressing that is safe to handle, the used materials must be precisely in coordination with one another. The used materials must be particularly coordinated in respect of their release characteristics. These release characteristics that are adjustable with additional means are based on the forces that exist between the two used materials. A targeted surface treatment of a material can for instance be used to adjust an attracting of rejecting effect in relation to a second material, which is to be joined with the first material. A surface treatment, which causes an attracting effect between two materials, can for instance follow due to an adhesive coating, a static charge or by amalgamating both materials that are to be joined. A rejecting effect can for instance be caused by an additional layer on a material of silicon or fluoride combinations. A release force (pull-off force) is thereby such a force that is necessary to separate two materials from one another (measured according to DIN 53530). In another embodiment of the foil dressing, these release characteristics are adjusted in such manner that the pull off force which is necessary to release a cover foil or paper from the polymer film to be applied is greater than the pull-off force which is necessary to release the supporting foil or the supporting foils from the polymer film.
-13 In an embodiment of the foil dressing with two supporting foils, the release characteristics are adjusted in such manner that the pull-off force which is necessary to release the first supporting foil from the polymer film that is to be applied is equal to the pull-off force that is necessary to release the second supporting foil. In a foil dressing with two supporting foils and two grip strips, the release characteristics are preferably adjusted in such manner that the pull-off force which is necessary to release the first grip strip from the second grip strip or to release the second from the first grip strip is less than the pull-off force that is necessary to release the supporting foil from the polymer film that is to be applied. In another embodiment of the foil dressing with two supporting foils, the release characteristics are preferably adjusted in such manner that the pull-off force, which is necessary to release the first supporting foil from the polymer film that is to be applied is greater than the pull-off force which is necessary to release the first grip strip from the second grip strip. The adhesion of the supporting foil on the polymer film is preferably only 0.01 to 0.5 NI 25 mm, especially preferred 0.01 to 0.1 N/ 25 mm, measured according to DIN 53630. The supporting material is preferably attached directly here to the polymer film during its manufacturing process, or the polymer film is manufactured directly on the supporting material, respectively. Further, all regular methods for the film manufacturing may be applied, such as melting, spreading, extrusion or other familiar methods for manufacturing of films or foils. If necessary, the supporting material can be roughened on the coated side or be subjected to another treatment that promotes adhesion. A coating that promotes adhesion can also be beneficial.
-14 It is in this important that the adhesion of the polymer film on the surface which is to be applied is substantially greater than the adhesion of a supporting foil to the polymer film. In a particular embodiment of the present invention, it is intended that a foil dressing including a polymer film with an application system is located inside of a package. It is particularly intended that the package is a sterile package. It must be emphasized at this point that the here referenced characteristics of the alternative developments of the inventions are not to be limited to the individual alternatives. It is rather the case that the combination of the developments and/or the combination of the individual characteristics of the alternative forms must be included in a development according to the present invention. The present invention shall be understood to be reduced just as little by the subsequent explanations of the illustrations. In a second aspect of the present invention, there is provided a foil dressing comprising a polymer film and an application system for permitting an improved ease of use of said foil dressing, in which the application system is located on a first side of the polymer film and comprises at least one first and one second supporting foil, wherein at least one first grip strip is formed on the first supporting foil and at least one second grip strip is formed on the second supporting foil, in which at least the first grip strip comprises a grip surface that enables the grip strip to be grasped and the first grip strip at least partially overlaps the second grip strip each grip strip being an additional material component and being removable from the polymer film simultaneously with at least one supporting foil, and wherein the area of the -15 polymer film which is covered by the supporting foils is smaller than the area of the first side of the polymer film, where the combined contact area of the supporting foils is less than 94% of the area of the first side of the polymer film. The present invention is described below with reference to the illustrations. The illustrations demonstrate: Figure 1: a foil dressing according to an embodiment of the present invention, in a top view Figure 2: the embodiment of a foil dressing as illustrated in Figure 1, in a cross section Figure 3: another embodiment of the foil dressing according to the present invention, in a top view Figure 4: the embodiment of a foil dressing as illustrated in Figure 3, in a cross section Figures 5 a-c: a foil dressing according to an embodiment of the present invention when applied, in a cross section Figure 1 and Figure 2 illustrate a first embodiment of the present invention. This foil dressing (20) has a rectangular basic form and comprises a polymer film (1), a continuous adhesive coating (2) that is applied on the second side of the polymer film, and a covering layer (3) that covers said adhesive. The polymer film has on its first side an application system, which comprises two supporting foils (22a, 22b), two grip strips (25, 26) as well as two adhesives (24a, 24b). These two supporting foils are attached to the polymer film in such a manner that said polymer film, with the exception of the non covered area (27), is completely covered except for the -16 supporting foils. The covered area of the polymer film comprises approximately 96 % of the area of the first side of the polymer film. In this development, the first grip strip (25), which is affixed to the first supporting foil (22b) by means of the first adhesive (24b) overlaps the area without a supporting foil (27) as well as the second grip strip (26) which is affixed to the second supporting foil (22a) by means of a second adhesive (24a). The first grip strip (25) comprises a grip surface which is formed as a rear-grasping device to enable the grip strip to be grasped. The outer portion of the grip surface protrudes peripherally as an exposed grip surface (251) beyond the second grip strip (26). This second grip strip (26) has in the illustrated embodiment no grip surface that is formed as a rear grasping device. This is, however, as illustrated in Figures 3 and 4 in the case of a patch used to affix hypodermic needles also possible and beneficial in order to improve the grasping of the second grip strip (26). Due to the fact that only one grip strip can be grasped and seen by the user, a sequence is pre-determined for the removal of both of the supporting foils. Figure 3 and Figure 4 illustrate another foil dressing (30). This foil dressing can be used as a patch to affix hypodermic needles or catheters. The foil dressing comprises a rectangular basic form, whereas its short side exhibits an indentation that is positioned parallel to the long side. This indentation gives the foil dressing two areas that are independent from one another which are attached through a third area and which, for instance during the positioning of a hypodermic needle, are always on one side of the hypodermic needle affixed to one surface. The foil dressing exhibits a polymer film (1), an acrylate-adhesive layer (2) and a covering layer (3) that covers the adhesive layer. An application system is positioned on the first side of the polymer film, which is positioned away from the adhesive layer. This application -17 system comprises two grip strips (35, 36) which are affixed on three supporting foils (32a, 32b, 32c) by means of three adhesives (34a, 34b, 35c). The first grip strip (35) is allocated to the first supporting foil (32c) as well as to the second supporting foil (32b) and thus formed to it. Both of these supporting foils (32c, 32b) can thus be removed in the same grasp. The first grip strip (35) overlaps the central areas of the polymer film which are not covered by supporting foils (37a, 37b), as well as the second grip strip (36). The outer portion of the grip surface protrudes as an exposed grip surface (351) peripherally beyond the second grip strip (26), whereas a sequence for the removal of said second grip strip (26) has been determined here as well. The supporting foils cover a total surface of the polymer film which is equal to 92 % of the surface of the first side of the polymer film, since in addition to the central areas (37a, 37b), which are not covered by supporting foils, a supporting foil is not positioned in either of the two marginal areas (38a, 38b) as well. These peripheral areas without supporting foils can be used for a first positioning after removal of the cover layer. Figure 4 also illustrates an activation device (39) between the two grip strips. This activation device (39) as well as the adhesive for the positioning of the grip strip (36) to the supporting foil (32a) is not illustrated in Figure 3. This activation device (39) is a double-sided adhesive tape which comprises a higher adhesive strength for the first grip strip (35) than for the second grip strip (36). This causes during the removal of the supporting foils (32b, 32c) by means of the first grip strip (35) to lift up the underlying second grip strip (36) before the adhesive force between the first grip strip (35) and the activation device (39) can be overcome. The second grip strip (36) is thus easier to grasp in the next step when removing the supporting foil (32a).
-18 Figures 5a to 5c illustrate the application of a foil dressing according to an embodiment of the present invention with two areas without supporting foils following the removal of the covering layer (3) from the adhesive layer (2). In order to apply, for instance, a foil dressing (30, 50) above a wound (W), as shown in Figures 5a to 5c, a first peripheral area without supporting foils (38a, 38b, 58) can therefore be positioned to an area that borders the wound (W). This is perfectly possible due to the high flexibility of the polymer film without the supporting foil. In an additional step, the user can then with help of the predetermined configuration of the grip strips (35, 36, 55, 56), which are affixed to the individual supporting foils by means of adhesives (34a, 34b, 34c, 54a, 54b) place the polymer film (1) which is to be applied directly above the wound. Due to the additional area (37a, 37b, 57) that is not covered by supporting foils, the foil dressing exhibits some kind of joint which allows for wrinkle-free application. The supporting foils (32a, 32b, 32c, 52a, 52b) can be successively removed during the application or following the application of the polymer film, whereas the first grip strip (33, 55) can initially be grasped by its exposed grip surface (351, 551) and the first supporting foil (32b, 32c, 52b) is then removed first. Embodiment 1: The foil dressing comprises a rectangular basic form with an edge length of 57 x 80 mm (contact surface 45.6 cm 2 ). It comprises a transparent polyether urethane film, which on the side that is positioned towards the body is coated with an acrylate-based hydrogel adhesive. The adhesive is affixed continuously in the amount of app. 35g/m 2 onto the app. 25 pm thick polymer film (measured with a test pressure of 0.5 kPa). The polymer film together with the -19 adhesive comprises a condensation permeability of approx. 2,600 g/ M2/ 24 hrs. (measured according to DIN EN 13726, with the difference that after 4 hrs. the measurement period was terminated and the determined result is extrapolated for 24 hrs.). Such a polymer film is available under the trade name Inspire 6200 from the company InteliCoat Technologies, Wrexham Industrial Estate, Wrexham LL13 9UF, UK. The adhesive side of this polymer film is available from the company Maria Soell GmbH & Co. KG, Frankenstrasse 45, D-63667 Nidda Eichelsdorf, with a siliconized cover paper and covered under the trade name Separacon 980-60. The other side of the polymer film, which during the application is positioned away from the body, comprises an application system which consists of two supporting foils that each has one grip strip. The supporting foils are, as illustrated in Figure 1 and Figure 2, positioned on the polymer film. The foil dressing at hand additionally realizes a peripheral area, which is not covered by a supporting foil or grip strip. This additional peripheral area without a supporting foil is positioned on the short side of the rectangle and comprises an equal width of 5 mm. Both of the supporting foils are equal in size and comprise an edge length of 57 x 36 mm (contact area: 2 x 20.5 cm2 = 41.0 cm 2 ) . The distance of both foils is 3 mm in each point of their parallel edges that are of equal length. This results for both supporting foils in a combined contact area of 90 % in respect of the surface of the first polymer film. The supporting foils are manufactured of a 30 pm thick polyester film (measured at a test pressure of 0.5 kPa). A grip strip is affixed onto each supporting foil with an acrylate adhesive. The grip strips together comprise a configuration, as illustrated in Figure 4, whereas the first grip strip, which is sketched with reference mark (35), has a size of 57 x 39 mm and is throughout the entire width (57 mm) attached to the respective supporting foil. The second grip strip, -20 which is illustrated with reference (36), comprises a size of 57 x 22 mm. Both grip strips are each attached to the respective supporting foil through a 5 mm wide adhesive connective strip and are manufactured from a 20 um thick transparent polyester film. The first grip strip thus has a strip surface with an equally formed width of 34 mm. The size of the grip surface of the first grip strip comprises 19.4 cm 2 . The equally shaped width of the grip surface of the second grip strip comprises 17 mm. The size of the grip surface of the second grip strip thus comprises 9.7 cm 2 . The equally shaped width of that portion which protrudes beyond the second grip strip of the first grip surface that is the width of the exposed grip surface of the first grip strip measures 9 mm. The size of the exposed grip surface thus comprises 5.1 cm 2 . Embodiment 2: The foil dressing comprises a rectangular basic form with an edge length of 57 x 80 mm (contact surface 45.6 cm 2 ). It comprises a transparent polyether urethane film which on the side that is positioned towards the body is coated with a pressure sensitive acrylate-based adhesive. The adhesive is affixed continuously in the amount of approx. 25 g/ m 2 onto the approx. 30 pm thick polymer film (measured with a test pressure of 0.5 kPa). The polymer film together with the adhesive comprises a condensation permeability of app. 1,200 g/ M 2 / 24 hrs. (measured according to DIN EN 13726). Such a polymer film is available under the trade name Inspire 1305 from the company InteliCoat Technologies, Wrexham Industrial Estate, Wrexham LL13 9UF, UK. The adhesive side of this polymer film is available from the company Maria Soell GmbH & Co. KG, Frankenstrasse 45, D-63667 Nidda Eichelsdorf, with a siliconized cover paper and covered under the trade name Separacon 980-60. The other side of the polymer film, which during the application is -21 positioned away from the body, comprises an application system which consists of two supporting foils that each has one grip strip. The supporting foils, as illustrated in Figure 1 and Figure 2, are positioned on the polymer film. The foil dressing at hand additionally realizes a peripheral area which is not covered by a supporting foil or grip strip. This additional peripheral area without a supporting foil is positioned on the short side of the rectangle and comprises an equal width of 5 mm. Both of the supporting foils are equal in size and comprise an edge length of 57 x 36 mm (contact area: 2 x 20.5 cm 2 = 41.0 cm 2 ) . The distance of both foils is 3 mm in each point of their parallel edges that are of equal length. This results for both supporting foils in a combined contact area of 90 % in respect of the surface of the first polymer film. The supporting foils are manufactured of a 30 pm thick polyester film (measured at a test pressure of 0.5 kPa). A grip strip is affixed onto each supporting foil with an acrylate adhesive. The grip strips in a cross-sectional view comprise a configuration, as illustrated in Figure 4, whereas the first grip strip, which is sketched with reference mark (35), has a size of 57 x 39 mm and is throughout the entire width (57 mm) attached to the respective supporting foil. The second grip strip, which is illustrated with reference mark (36), comprises a size of 57 x 22 mm. Both grip strips are each attached to the respective supporting foil through a 5 mm wide adhesive connective strip and are manufactured from a 20 pm thick transparent polyester foil. The first grip strip thus has a strip surface with an equally formed width of 34 mm. The size of the grip surface of the first grip strip comprises 19.4 cm 2 . The equally shaped width of the grip surface of the second grip strip comprises 17 mm. The size of the grip surface of the second grip strip thus comprises 9.7 cm 2 . The equally shaped width of that portion which protrudes -22 beyond the second grip strip of the first grip surface that is the width of the exposed grip surface of the first grip strip measures 9 m. The size of the exposed grip surface thus comprises 5.1 cm 2 . The release characteristics of the materials used in this embodiment 2 were determined on 60 x 80 mm test sections according to the method described in DIN 53 530. The tests were completed with a pull-off velocity of 300 mm/min. The silicon paper in respect of the polymer film therefore exhibits a release force of 0.77 N/ 25 mm, whereas the supporting foil in respect of the polymer film exhibits a release force of 0.09 N/ 25 mm. The release characteristics of this foil dressing are hence adjusted such that the pull-off force which is necessary to release a cover foil from the polymer film that is to be applied is greater than the pull-off force which is necessary to separate the supporting foil or the supporting foils from the polymer film. It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country. In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.
Application No. 2006220045 Editorial Note: The claims pages start from page no. 24

Claims (16)

1. A foil dressing comprising a polymer film and an application system for permitting an improved ease of 5 use of said foil dressing, in which the application system is located on a first side of the polymer film and comprises at least one first and one second supporting foil, wherein at least one first grip strip is formed on the first supporting foil and at least one 10 second grip strip is formed on the second supporting foil, in which at least the first grip strip comprises a grip surface that enables the grip strip to be grasped and the first grip strip at least partially overlaps the second grip strip, each grip strip being 15 an additional material component and being removable from the polymer film simultaneously with at least one supporting foil, and wherein the area of the polymer film which is covered by the supporting foils is smaller than the area of the first side of the polymer 20 film, where the combined contact area of the supporting foils is less than 94% of the area of the first side of the polymer film.
2. Foil dressing according to Claim 1, wherein the first 25 grip strip completely overlaps the second grip strip and comprises an exposed grip surface of at least 2 cm 2 30
3. Foil dressing according to at least one of the previous claims, wherein the polymer film comprises at least an area without supporting foils.
4. Foil dressing according to at least one of the previous 35 claims, wherein the first or the second grip strip overlaps at least partially a first area without supporting foils. 2648308_1 (GHMatters) P75947.AU 6/05/11 - 25
5. Foil dressing according to at least one of the previous claims, wherein the application system 5 comprises the same size as the polymer film.
6. Foil dressing according to at least one of the previous claims, wherein the polymer film comprises a peripheral area without supporting foils. 10
7. Foil dressing according to at least one of the previous claims, wherein a first area without supporting foils of the polymer film is positioned between the first and the second supporting foil. 15
8. Foil dressing according to at least one of the previous claims, wherein the polymer film comprises at least two areas without supporting foils that are separated from one another. 20
9. Foil dressing according to at least one of the previous claims, wherein the supporting foils and the grip strips are comprised of identical materials. 25 1o.
Foil dressing according to at least one of the previous claims, wherein the first grip strip is more rigid than the second grip strip. 30
11. Foil dressing according to at least one of the previous claims, wherein the second side of the polymer film is coated with an adhesive material, for example continuously with an adhesive material and the adhesive material is covered with a release foil or paper. 35
12. Foil dressing according to at least one of the previous claims, wherein a wound pad is attached to 2648308_1 (GHMatters) P75947.AU 6l11 - 26 the second side of the polymer film.
13. Foil dressing according to at least one of the previous claims, wherein a layer that promotes the healing of 5 the wound is attached to the second side of the polymer film.
14. Foil dressing according to at least one of the previous claims, wherein the polymer film is comprised of a 1o polyurethane film, polyester urethane film or polyether urethane film.
15. Foil dressing according to at least one of the is previous claims, wherein the supporting foils are positioned on one level.
16. Foil dressing substantially as herein described with reference to one or more of the drawings. 20 2648308_1 (GHMatters) P75947.AU60511
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DE102005009635A DE102005009635A1 (en) 2005-03-03 2005-03-03 Foil dressing with application aid
DE102005009635.2 2005-03-03
PCT/EP2006/001732 WO2006092244A1 (en) 2005-03-03 2006-02-24 Film dressing comprising an application aid

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ES2326338T3 (en) 2009-10-07
US20080281245A1 (en) 2008-11-13
US9271873B2 (en) 2016-03-01
EP1853209A1 (en) 2007-11-14
EP1853209B1 (en) 2009-05-13
DK1853209T3 (en) 2009-08-10
WO2006092244A1 (en) 2006-09-08
AU2006220045A1 (en) 2006-09-08
JP2008531153A (en) 2008-08-14
JP4823240B2 (en) 2011-11-24
ATE431121T1 (en) 2009-05-15
DE502006003715D1 (en) 2009-06-25

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